Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

Last updated on July 2021

Recruitment

Recruitment Status: Enrolling by invitation
Estimated Enrollment: Same as current

Summary

Conditions

Open Appendicular Fracture
Surgical Site Infection
Unplanned Fracture-Related Reoperation

Type

Interventional

Phase

Phase 4

Design

Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Treatment allocation will be determined using a cluster-randomized crossover trial design. The order of treatment allocation for each orthopaedic practice will be randomly assigned using a computer generated randomization table. Each site will start with the initially allocated study solution and eventually crossover to the other solution for their second recruitment period. This process of alternating treatments will repeat approximately every 2 months as dictated by the initial randomization.Masking: Single (Outcomes Assessor)Masking Description: The orthopaedic team (including the study coordinators) cannot be blinded to the treatment allocation as the antiseptic solutions are visually distinguishable and these individuals need to lead the implementation of the cluster-crossover protocol at their clinical site. The Adjudication Committee Members and data analysts will be blinded to the study treatment. All interpretation of study results will initially be done in a blinded manner by developing two interpretations of the results. One interpretation will assume treatment A is povidone-iodine, the other interpretation will assume it is CHG. Once the data interpretations for each assumption are finalized, the data will be unblinded and the correct interpretation will be accepted.Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #

NCT03385304

Collaborators

McMaster University
United States Department of Defense

Investigators

Principal Investigator: Gerard Slobogean, MD University of Maryland Shock Trauma Center Principal Investigator: Sheila Sprague, PhD McMaster University Principal Investigator: Mohit Bhandari, MD McMaster University